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U.S. Department of Health and Human Services

Class 3 Device Recall Assayed Bovine MultiSera Level 1

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 Class 3 Device Recall Assayed Bovine MultiSera Level 1see related information
Date Initiated by FirmJune 10, 2019
Create DateAugust 07, 2019
Recall Status1 Terminated 3 on June 16, 2020
Recall NumberZ-2207-2019
Recall Event ID 83153
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductAssayed Bovine Multi-Sera Level 1, Model No. AL1027
Code Information 205SL
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore; 55 The Diamond Road
Crumlin United Kingdom
Manufacturer Reason
for Recall		The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
FDA Determined
Cause 2		Process design
ActionOn June 7, 2019, the firm notified customers of the recall by issuing an Urgent Medical Device Correction letter. Customers were asked to take the following actions: * Inspect your stock and quarantine affected stock on hand to prevent further use. " Discard all value sheets and replace these with the value :sheets provided. " A review of previously generated patient results is not required as control failure is evident at the time of testing. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. *Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. If you have any questions or concerns, please contact Rand ox Technical Services.
Quantity in Commerce4 kits (US)
DistributionDomestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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